Background There is limited data on outcomes in cancer patients with coronavirus disease 2019 (COVID‐19) from lower middle‐income countries (LMICs). Patients and Methods This was an observational study, conducted between 12 April and 10 June 2020 at Tata Memorial centre, Mumbai, in cancer patients undergoing systemic therapy with laboratory confirmed COVID‐19. The objectives were to evaluate cumulative 30‐day all‐cause mortality, COVID‐19 attributable mortality, factors predicting mortality, and time to viral negativity after initial diagnosis. Results Of the 24 660 footfalls and 7043 patients evaluated, 230 patients on active systemic therapy with a median age of 42 (1‐75) years were included. COVID‐19 infection severity, as per WHO criteria, was mild, moderate, and severe in 195 (85%), 11 (5%), and 24 (11%) patients, respectively. Twenty‐three patients (10%) expired during follow‐up, with COVID‐19 attributable mortality seen in 15 patients (6.5%). There were no mortalities in the pediatric cohort of 31 (14%) patients. Advanced stage cancer being treated with palliative intent vs others [30‐day mortality 24%% vs 5%, odds ratio (OR) 5.6, 95% CI 2.28‐13.78, P < .001], uncontrolled cancer status vs controlled cancer (30‐day mortality37.5%% vs 4%%, OR 14, 95% CI 4.46‐44.16, P < .001) and severe COVID‐19 vs mild COVID‐19 (30‐day mortality 71% vs 3%, OR 92.29, 95% CI 26.43‐322.21, P < .001) were significantly associated with mortality. The median time to SARS‐CoV‐2 RT‐PCR negativity was 17 days [interquartile range (IQR)17‐28) in the cohort. Conclusions The mortality rates in cancer patients with COVID‐19 who are receiving systemic anti‐cancer therapy in LMICSs are marginally higher than that reported in unselected COVID‐19 cohorts with prolonged time to viral negativity in a substantial number of patients. The pediatric cancer patients tended to have favorable outcomes.
Background: Older patients with cancer are underrepresented in most immunotherapy trials. Therefore, there is an urgent and unmet need for real-world data on the efficacy and safety of immune checkpoint inhibitors (ICIs) in older patients with cancer. Objectives: This study was aimed at analyzing the demographic pattern, treatment-related outcomes, and toxicities of ICIs in older patients with solid tumors. Materials and Methods: This retrospective study was conducted in the Department of Medical Oncology of the Tata Memorial Hospital, a tertiary cancer care center in Mumbai, India. Patients aged ≥ 60 years with histologically confirmed malignancies of the thoracic, head and neck and genitourinary systems who were treated with ICIs between August 2014 and February 2021, and had received at least 2 cycles of ICI were enrolled in the study. Data related to the demographic profile and pattern of care were obtained from the electronic medical records and physical patient files. Patient management was decided in a multidisciplinary tumor board meeting. The primary endpoint of the study was overall survival (OS). The secondary endpoints were objective response rate (ORR), progression-free survival (PFS), and rate of immune-related adverse events. Results: There were 150 patients included in the study. The most common indications for ICI use were non-small-cell lung cancer (52.7%) and head and neck squamous cell carcinoma (17.3%). Nivolumab was the most common ICI used in 119 (79.4%) patients. ICIs were used in the palliative setting in 144 (96%) patients. A total of 76 (50.6%) patients received ICIs as second-line therapy. The median number of cycles of ICI received was 5 (interquartile range, 3.0–9.5). The ORR to ICIs was 30%, and the clinical benefit rate was 52%. ICIs were discontinued due to toxicities in 4 (2.7%) patients. The median PFS and OS were 4.23 (95% confidence interval [CI], 1.38–7.08) months and 8.6 (95% CI, 4.9–12.2) months, respectively. Baseline performance status was the most significant prognostic factor for PFS and OS in the multivariate analysis. In addition, age, male sex, and comorbid conditions such as chronic kidney disease negatively impacted the OS. Conclusion: Our study shows that ICIs are efficacious and well tolerated in older Indian patients with solid tumors. There is an emerging need for larger prospective studies on ICIs with the incorporation of geriatric assessment scores in this vulnerable patient population.
PURPOSE There is a lack of published literature on systemic therapeutic options in cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing chemoradiation. Docetaxel was assessed as a radiosensitizer in this situation. METHODS This was a randomized phase II/III study. Adult patients (age ≥ 18 years) with LAHNSCC planned for chemoradiation and an Eastern Cooperative Oncology Group performance status of 0-2 and who were cisplatin-ineligible were randomly assigned in 1:1 to either radiation alone or radiation with concurrent docetaxel 15 mg/m2 once weekly for a maximum of seven cycles. The primary end point was 2-year disease-free survival (DFS). RESULTS The study recruited 356 patients between July 2017 and May 2021. The 2-year DFS was 30.3% (95% CI, 23.6 to 37.4) versus 42% (95% CI, 34.6 to 49.2) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.673; 95% CI, 0.521 to 0.868; P value = .002). The corresponding median overall survival (OS) was 15.3 months (95% CI, 13.1 to 22.0) and 25.5 months (95% CI, 17.6 to 32.5), respectively (log-rank P value = .035). The 2-year OS was 41.7% (95% CI, 34.1 to 49.1) versus 50.8% (95% CI, 43.1 to 58.1) in the RT and Docetaxel-RT arms, respectively (hazard ratio, 0.747; 95% CI, 0.569 to 0.980; P value = .035). There was a higher incidence of grade 3 or above mucositis (22.2% v 49.7%; P < .001), odynophagia (33.5% v 52.5%; P < .001), and dysphagia (33% v 49.7%; P = .002) with the addition of docetaxel. CONCLUSION The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC.
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